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Type 2 Diabetes (T2D)STEATO-POMPENCT04270656

Liver and Metabolic Effects of Insulin Pump Therapy in Diabetics Type 2 with Non-alcoholic Hepatic Steatosis

A study testing Insulin pump therapy and Multi-injection treatment ( MDI ). in people with Type 2 Diabetes (T2D), run by Nantes University Hospital at 9 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The prevalence of fatty liver disease (NAFLD: Non-Alcoholic Fatty Liver Disease or to a more severe degree NASH: Non-Alcoholic SteatoHepatitis) reached 40-70% in subjects with type 2 diabetes (T2D). NAFLD can be easily detected by performing a hepatic ultrasonography. Read more about this study

Who is it for?
Ages 37 to 70 years
Conditions the study is for
Type 2 Diabetes (T2D)
What is being tested?
Insulin pump therapy and Multi-injection treatment ( MDI ).
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
9 sitesFrance
Study dates
5 Feb 2021to 23 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 37 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male / female 35/70 years (including ranges) with T2D ≥ 1 year
  • Benefiting from the indication of use of the free Freestyle glucose meter
  • Treatment with multi-injection insulin therapy comprising a daily injection of basal insulin (Glargine U100, Glargine U300, Degludec) and at least 2 daily injections of an insulin analogue (lispro, aspart or glulisine) +/- metformin, dipeptidyl peptidase-4 (DPP4) and/or sodium-glucose cotransporter type 2 (SGLT2) at a dose stable for at least 3 months.
  • For women of childbearing age, oestro-progestative pill, IUD, implant.
  • 11% ≥ HbA1c ≥ 6.5%
  • Presence of hepatic steatosis according to the ultrasonography
  • Absence of chronic alcoholic intoxication
  • Absence of chronic viral hepatitis or other chronic liver diseases (eg hemochromatosis ...)

Who cannot join

  • Type 1 diabetes
  • Contraindication to pump treatment
  • Treatment with anti-diabetics or other than metformin, dipeptidyl peptidase-4 (DPP4) and/or sodium-glucose cotransporter type 2 (SGLT2)
  • Treatment with basal inulin of Levemir
  • Contraindication to performing MRI
  • Chronic alcohol abuse (after alcohol consumption> 20g / day in men and> 10g / day in women) according to the medical examination
Show all 17Show fewer
  • Chronic viral hepatitis based on HBV and HCV serology results
  • Hemochromatosis according to the martial assessment
  • Other toxic or drug hepatitis
  • Severe hepatic pathology: hepatic cirrhosis, hepatocellular carcinoma
  • Severe renal insufficiency (MDRD <30 ml / min)
  • Severe and progressive cardiovascular pathology
  • Treatment (permanent or intermittent) with glucocorticoids
  • Treatment known to improve hepatic steatosis (glitazone, vitamin E, orlistat)
  • history or bariatric surgery project for the duration of the study
  • Drug treatment likely to cause hepatic steatosis (amiodarone, carbamazepine, tamoxifen, valproate, clozapine, anti-retroviral drugs) unless the dose has been stable for ≥ 3 months
  • Guardianship, curatorship or safeguard of justice

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

France9 sites

  • CHU

    Angers, 49933

  • CHU

    Caen, 14033

  • CHU

    Dijon, 21000

  • CHU

    La Rochette, 17019

  • Hospices Civils

    Lyon, 69495

  • Nantes UH

    Nantes, 44093

  • CHU

    Poitiers, 86000

  • CHU de Rennes

    Rennes, 35203

  • CHU

    Toulouse, 31059

Other trials in France

About this study

Official title: Liver and Metabolic Effects of Insulin Pump Therapy in a Population of Type 2 Diabetics with Non-alcoholic Hepatic Steatosis

The prevalence of fatty liver disease (NAFLD: Non-Alcoholic Fatty Liver Disease or to a more severe degree NASH: Non-Alcoholic SteatoHepatitis) reached 40-70% in subjects with type 2 diabetes (T2D). NAFLD can be easily detected by performing a hepatic ultrasonography. The presence of a NAFLD is positively correlated with the severity of insulin resistance and dysglycemia in this population. The presence of NAFLD worsens the prognosis of T2D with an increased cardiovascular risk. This hepatic impairment would also increase the risk of microvascular complications, especially nephropathy. Conversely, T2D increases the risk of transition from NAFLD to NASH and then to hepatic fibrosis and its related complications (cirrhosis, hepatocellular carcinoma). The risk of progression of liver steatosis to fibrosis is also more important as diabetes and insulin resistance are more severe.

In addition to diabetes and insulin resistance, other risk factors are associated with more severe liver damage such as changes in microbiota. Indeed, it has already been described a smaller amount of bacteroides in the microbiota of subjects with T2D and the most severe hepatic impairment. The treatment of NAFLD/NASH is poorly codified without approved drugs in this indication, while many phase 3 trials with candidate drugs are undergoing. Life-style measures (physical activity and low carbohydrate/calorie diet) can limit the progression from NAFLD to more severe liver fibrosis. Some bariatric surgery studies have also shown good results in this situation. Pharmacological interventions are also reported with proven efficacy of pioglitazone, vitamin E and orlistat.

Read more

The OPT2MISE study has recently shown the superiority of insulin pump (or continuous sub-cutaneous insulin infusion: CSII) compared to multiple daily insulin injections (MDI) to improve glycemic control in a population of patients with T2D in failure of well-titrated MDI. In addition, treatment with CSII showed a 45% decrease in insulin resistance (assessed by HOMA-IR) in a population of newly diagnosed T2D.

In light of these data, investigators hypothesize that the introduction of insulin pump treatment in a population of subjects with T2D and NAFLD, by improving insulin sensitivity, could reduce fatty liver content compared to standard MDI treatment.

Being tested
Insulin pump therapy, Multi-injection treatment ( MDI ).
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insulin pump therapyProcedure or surgery

    5-day hospitalization in case of randomization in the insulin pump group (insulin pump establishing in according to the recommendations of the HAS)

  • Multi-injection treatment ( MDI ).Procedure or surgery

    Corresponds to an outpatient visit if the patient is randomized into the multi-injection group

Study groups in NCT04270656
Study groupRoleWhat they receive
Insulin pump therapyExperimentalNot described
Receives: Procedure: Insulin pump therapy
Multi-injection treatment ( MDI ).Active comparatorNot described
Receives: Procedure: Multi-injection treatment ( MDI ).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Variation of hepatic steatosis, between the insulin pump therapy (CSII) vs Multi injection treatement (MDI) groups.

    Change of fatty liver by MRI quantification

    Measured: 6 months

Secondary outcomes (22)

  1. In the CSII group : avantage of an insulin pump treatment on the fatty liver between inclusion and the 6th month,

    Variation of hepatic steatosis (MRI quantization by gradient echo sequences \& centralized reading

    Measured: 6 months

  2. In the CSII group : avantage of an insulin pump treatment on the fatty liver (quantified by MRI), between inclusion and the 12th month,

    Variation of hepatic steatosis (MRI quantization by gradient echo sequences \& centralized reading

    Measured: 12 months

  3. Evaluate the effectiveness of a CSII vs MDI treatment, between randomization and 6 months, on hepatic biological parameters and non-invasive biomarkers of fatty liver (FLI) and of fibrosis of the liver (FIB-4 and NAFLD Score),

    Liver fonction (AST ; ALAT ; GGT ; PAL ; Ferritin) Test-fibrosis score criteria (FIB- 4 and NAFLD Score) ; FLI

    Measured: 6 months

  4. Evaluate the effectiveness of a CSII vs MDI treatment, between randomization and 6 months on insulin sensitivity

    dosage of plasma adiponectin

    Measured: 6 months

  5. Evaluate the effectiveness of a CSII vs MDI treatment, between randomization and 6 months on insulin sensitivity

    calculation of the modified HOMA-IR index (peptide C, blood sugar),

    Measured: 6 months

  6. Evaluate the effectiveness of a CSII vs MDI treatment, between randomization and 6 months on glycemic balance

    HbA1c dosages

    Measured: 6 months

  7. Evaluate the effectiveness of a CSII vs MDI treatment, between randomization and 6 months on the total daily insulin dose

    daily insulin dose record

    Measured: 6 months

  8. Evaluate the effectiveness of a CSII vs MDI treatment, between randomization and 6 months on lipid profile • the inflammatory condition

    total cholesterol

    Measured: 6 months

  9. Evaluate the effectiveness of a CSII vs MDI treatment, between randomization and 6 months on lipid profile • the inflammatory condition

    LDL-cholesterol

    Measured: 6 months

  10. Evaluate the effectiveness of a CSII vs MDI treatment, between randomization and 6 months on lipid profile • the inflammatory condition

    HDL-cholesterol

    Measured: 6 months

  11. Evaluate the effectiveness of a CSII vs MDI treatment, between randomization and 6 months on lipid profile • the inflammatory condition

    triglycerides (TG)

    Measured: 6 months

  12. Evaluate the effectiveness of a CSII vs MDI treatment, between randomization and 6 months on lipid profile • the inflammatory condition

    fatty-free acids

    Measured: 6 months

  13. Evaluate the effectiveness of a CSII vs MDI treatment, between randomization and 6 months on lipid profile • the inflammatory condition

    ApoB,

    Measured: 6 months

  14. Evaluate the effectiveness of a CSII vs MDI treatment, between randomization and 6 months on CRPus

    Ultra-sensitive C-reactive protein (CRPus)

    Measured: 6 months

  15. Evaluation of quality of life

    DTSQ

    Measured: 6 months

  16. Evaluation of quality of life

    SF36

    Measured: 6 months

  17. Safety analysis at 6 months: comparison the first 6 months, in the CSII and MDI groups:

    Reporting by patient of all severe hypoglycemia during the study

    Measured: 6 months

  18. Safety analysis at 6 months: comparison the first 6 months, in the CSII and MDI groups:

    Reporting by the patient of all episode of ketoacidosis during the study

    Measured: 6 months

  19. Calculation of the sensitivity values of the FLI for the detection of fatty liver in this population,

    quantification of hepatic MRI as Gold Standard.

    Measured: 6 months

  20. Calculation of the specificity values of the FLI for the detection of fatty liver in this population, by using the quantification of hepatic MRI as Gold Standard.

    quantification of hepatic MRI as Gold Standard.

    Measured: 6 months

  21. Calculation of the positive predictive values of the FLI for the detection of fatty liver in this population, by using the quantification of hepatic MRI as Gold Standard.

    quantification of hepatic MRI as Gold Standard.

    Measured: 6 months

  22. Calculation negative predictive values of the FLI for the detection of fatty liver in this population, by using the quantification of hepatic MRI as Gold Standard.

    quantification of hepatic MRI as Gold Standard.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2020
  2. Study start5 Feb 2021
  3. Primary completion23 Sep 2024
  4. Study completion23 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04270656
Sponsor's protocol ID
RC19_0449
Acronym
STEATO-POMPE
Status last verified
Oct 2024
First submitted
10 Feb 2020
Last updated
17 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Insulin pump therapy and Multi-injection treatment ( MDI ). in people with Type 2 Diabetes (T2D), run by Nantes University Hospital at 9 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Variation of hepatic steatosis, between the insulin pump therapy (CSII) vs Multi injection treatement (MDI) groups. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04270656.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.

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